(90 days)
APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.
The subject device includes various designs for internal fixation of the distal tibia and distal fibula; additional lengths of 3.5 TriLock Screws (locking screws, other lengths cleared in K110908); a new design of 3.5 Cortical Screws (non-locking) in various lengths; and a new design of concave washer for use with Medartis 3.5 Cortical Screws. The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The plat designs include: 3.5 TriLock Distal Tibia L Plates and T Plates; 2.8/3.5 TriLock Distal Tibia Plates Medial; 2.8/3.5 TriLock Distal Tibia Plates Anterolateral; 2.8/3.5 TriLock Distal Fibula Plates Lateral, with and without Flap; 2.8 TriLock Distal Fibula Plates Crossed; and 2.8 TriLock Distal Fibula Plates Straight. The subject device plates are used with TriLock locking screws and non-locking screws (cortical and cancellous), including subject device screws and previously cleared Medartis screws. Compatible TriLock locking screws and non-locking cortical screws have a diameter of 2.8 mm and 3.5 mm, and overall lengths ranging from 8 mm to 60 mm. The 2.8 Cortical Screws (non-locking) and 3.5 Cortical Screws (non-locking) have a double-lead thread design. All TriLock Screws (locking) have a double-lead thread design. The subject device plates also are compatible with Medartis K-Wires cleared in K092038. The subject device screws include screws with the same design as 3.5 TriLock Screws cleared in K110908, with a diameter of 3.5 mm and provided in additional lengths of 10 mm, 12 mm, and 14 mm. The subject device screws also include a new design of 3.5 Cortical Screws provided with a diameter of 3.5 mm and lengths of 10 mm to 60 mm. The subject device plates, washer, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. The subject device components are provided non-sterile to the end user.
The provided document is a 510(k) summary for the Medartis AG APTUS® Ankle Trauma System 2.8/3.5. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It focuses on the non-clinical performance data (biocompatibility, sterilization, engineering analysis, and mechanical testing) to demonstrate equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons of technological characteristics. The "reported device performance" is essentially that it met the requirements of these non-clinical tests and is comparable to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Referenced from previously cleared devices (K091479, K103332, K192297, and K191848). Implied to meet established biocompatibility standards. |
| Sterilization (for non-sterile components) | To be sterilized by moist heat (by the end-user), referenced from previously cleared devices (K091479, K103332, K192297, and K191848). Implied to meet sterilization efficacy. |
| Sterilization (for sterile components) | X-ray beam sterilization, referenced from K191848. Implied to meet sterilization efficacy. |
| Packaging and Sterile Barrier Shelf Life | Referenced from K191848. Implied to meet standards for maintaining sterility over time. |
| Engineering Analysis (Structural Integrity/Design Validation) | Performed. Details not provided, but implies the design is sound and comparable to predicate devices. |
| Mechanical Testing (e.g., strength, fatigue) | Performed according to ASTM F382 (Standard Specification for Metallic Bone Plates) and ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws). The document explicitly states the primary predicate device K013248 "is in support of substantial equivalence in terms of comparison mechanical testing" and additional predicate devices are for "comparative mechanical testing." |
| Material Composition | Plates: Unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. Screws: Ti-6Al-4V alloy, ASTM F136. Washer: Titanium alloy conforming to ASTM F136. This aligns with predicate and reference devices. |
| Indications for Use | Demonstrated as substantially equivalent to predicate devices, noting minor differences that do not impact substantial equivalence. |
| Technological Characteristics (Design, Components, Manufacturing) | Demonstrated as substantially equivalent to predicate devices, noting similar designs, compatible components, and identical manufacturing processes and materials for Medartis AG devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Clinical data were not provided in this submission." This means there was no human-patient-based test set. All data presented (biocompatibility, sterilization, mechanical testing, engineering analysis) are non-clinical.
- Sample Size for Test Set: Not applicable, as no clinical test set was used.
- Data Provenance: Non-clinical (laboratory/bench testing, engineering analysis). No country of origin for human data as none was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a metallic bone fixation system, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance evaluation is based on established engineering and materials standards (e.g., ASTM F382, ASTM F543, ASTM F67, ASTM F136), and documented performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable, as no machine learning algorithm requiring a training set was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no machine learning algorithm requiring a training set was used.
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March 26, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medartis AG % Kevin A. Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 EL Camino Real. Suite 400 San Diego, California 92130
Re: K193633
Trade/Device Name: APTUS® Ankle Trauma System 2.8/3.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC, HTN Dated: December 27, 2019 Received: December 27, 2019
Dear Kevin Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali. MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
APTUS® Ankle Trauma System 2.8/3.5
Indications for Use (Describe)
APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, malunions and non-unions of the distal tibia and fibula.
| Type of Use (Select one or both, as applicable) |
|---|
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K193633
Medartis AG
APTUS® Ankle Trauma System 2.8/3.5
February 24, 2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medartis AGHochbergerstrasse 60ECH-4057 Basel, SwitzerlandTelephone: +41 61 633 34 34Fax: +41 61 633 34 00 |
|---|---|
| Official Contact | Andrea Kiefer-SchweizerHead of Quality Management and Regulatory Affairs |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 858-792-1235Fax: +1 858-792-1236 |
Email:
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | APTUS® Ankle Trauma System 2.8/3.5 |
|---|---|
| Common Name | Plate, fixation, bone |
| Classification Name | Single/multiple component metallic bone fixation appliancesand accessories |
| Classification Regulation | 21 CFR 888.3030 |
| Product Code | HRS |
| Classification Panel | Orthopedic |
| Reviewing Office | Office of Health Technology 6 (Orthopedic Devices) |
| Reviewing Division | Division of Health Technology 6 C(Restorative, Repair and Trauma Devices) |
kthomas@paxmed.com flarson@paxmed.com
PREDICATE DEVICE INFORMATION
Primary Predicate Device K013248, Synthes (USA) LCP Distal Tibia Plates, Synthes (USA)
Additional Predicate Devices K092812, Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates, Synthes (USA) K011335, Synthes One-third Tubular DCL Plate, Synthes (USA) K083213, Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, Synthes (USA) K000684, Small Fragment Dynamic Compression Locking (DCL) System, Synthes (USA) K091479, APTUS® Foot System, Medartis AG
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Reference Devices K103332, APTUS® Ulna Plates, Medartis AG K 192297. APTUS® Wrist Arthrodesis Plates, Medartis AG K191848, APTUS® Wrist Spanning Plates 2.5, Medartis AG.
INDICATIONS FOR USE STATEMENT
APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.
SUBJECT DEVICE DESCRIPTION
The subject device includes various designs for internal fixation of the distal tibia and distal fibula; additional lengths of 3.5 TriLock Screws (locking screws, other lengths cleared in K110908); a new design of 3.5 Cortical Screws (non-locking) in various lengths; and a new design of concave washer for use with Medartis 3.5 Cortical Screws.
The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The plat designs include: 3.5 TriLock Distal Tibia L Plates and T Plates; 2.8/3.5 TriLock Distal Tibia Plates Medial; 2.8/3.5 TriLock Distal Tibia Plates Anterolateral; 2.8/3.5 TriLock Distal Fibula Plates Lateral, with and without Flap; 2.8 TriLock Distal Fibula Plates Crossed; and 2.8 TriLock Distal Fibula Plates Straight.
The subject device plates are used with TriLock locking screws and non-locking screws (cortical and cancellous), including subject device screws and previously cleared Medartis screws. Compatible TriLock locking screws and non-locking cortical screws have a diameter of 2.8 mm and 3.5 mm, and overall lengths ranging from 8 mm to 60 mm. The 2.8 Cortical Screws (non-locking) and 3.5 Cortical Screws (non-locking) have a double-lead thread design. All TriLock Screws (locking) have a double-lead thread design. The subject device plates also are compatible with Medartis K-Wires cleared in K092038.
The subject device screws include screws with the same design as 3.5 TriLock Screws cleared in K110908, with a diameter of 3.5 mm and provided in additional lengths of 10 mm, 12 mm, and 14 mm. The subject device screws also include a new design of 3.5 Cortical Screws provided with a diameter of 3.5 mm and lengths of 10 mm to 60 mm.
The subject device plates, washer, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136.
The subject device components are provided non-sterile to the end user.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility referenced from K091479, K103332, K192297, and K191848; moist heat sterilization (to be performed by the end user) also referenced from K091479, K103332, K192297, and K191848; X-ray beam sterilization, packaging, and sterile barrier shelf life referenced from K191848; engineering analysis; and mechanical testing according to ASTM F382 and ASTM F543. Clinical data were not provided in this submission.
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EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the primary predicate device, the additional predicate devices, and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements (IFUS) and the technological characteristics of the subject device, the primary predicate device, the additional predicate devices, and the reference devices.
The primary predicate device K013248 is in support of substantial equivalence in terms of comparable IFUS, plate designs (including use with locking and non-locking screws), screw designs, and materials. The primary predicate device K013248 also is in support of substantial equivalence in terms of comparison mechanical testing.
The additional predicate devices K092812, K011335, K083213, K000684 are in support of substantial equivalence in terms of comparable plate designs (including use with locking and non-locking screws), and for comparative mechanical testing.
The additional predicate device K091479 is in support of substantial equivalence in terms of comparable plate designs (including use with locking and non-locking screws), compatible screws and screw designs, and identical materials (unalloyed titanium conforming to ASTM F67 and titanium alloy conforming to ASTM F136).
The reference device K103332 is in support of substantial equivalence in terms of comparison mechanical testing.
The reference device K192297 is in support of substantial equivalence in terms of identical plate material (ASTM F67), and identical materials for the Class II accessories and instruments.
The reference device K191848 is in support of substantial equivalence in terms of identical plate material (ASTM F136), and for sterilization and shelf life for product provided sterile to the end user.
The subject device, the primary predicate device, the additional predicate devices, and the reference devices have the same intended use for internal fixation of bones including the lower extremity. The IFUS for K013248, K092812, K083213, K000684 include specific language referencing the tibia, fibula, or both.
Differences among the IFUS for the subject device, the primary predicate device, the additional predicate devices, and the reference devices include specific language not in the subject device IFUS referring to internal fixation of bones other than the lower extremity, or the use in osteopenic bone (K013248, K092812, K083213, K000684). The IFUS for the reference devices K103332, K192297, and K191848 include language referring to internal fixation of the upper extremity. These minor differences do not impact substantial equivalence because all IFUS express equivalent intended use for internal fixation of various bones.
The plates from the subject device and the plates cleared in K091479, K103332, K192297, and K191848 have the same technological characteristics, have similar design characteristics, include screw holes to accommodate locking and non-locking screws, and are made of identical materials.
The plates from the subject device, the primary predicate device K013248, and the additional predicate devices K092812, K011335, K083213, and K000684 have similar designs for specific anatomic locations and encompass a similar range of physical dimensions (overall length, and thickness).
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The plates from the subject device are compatible with subject device screws and with Medartis AG screws cleared in K091479, and also are compatible with Medartis AG K-Wires cleared in K092038.
All of the subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the Medartis AG devices cleared in K091479. K103332, K192297, and K191848, and, therefore, are substantially equivalent to these devices regarding biocompatibility.
The subject device includes components that are provided non-sterile and components that are provided sterile. The subject device components that are provided non-sterile are packaged using the same materials, and are to be sterilized by the same methods as the Medartis AG devices cleared in K091479. K 103332, and K 192297. The subject device components that are provided sterile to the end user are packaged using the same materials, are to be sterilized by the same method, and have the same sterile barrier shelf life as the Medartis AG devices cleared in K191848.
The differences among the plates from the subject device, the primary predicate device, the additional predicate devices, and the reference devices include variations in the designs of the plates (number of designs, overall dimensions, placement of screw holes), and variations in the sizes of the compatible screws. The plates from the primary predicate device K013248 and from the additional predicate devices K092812, K011335, K083213, and K000684 are made of a different titanium alloy material compared to the subject device. These slight differences among the subject device, the primary predicate, and reference devices do not impact safety or effectiveness.
The subject device screws have similar designs and are made of the identical as the Medartis AG devices cleared in K091479 and K103332.
The subject device washer is made of the identical titanium alloy conforming to ASTM F136 as the subject device plates and screws and has a design similar to the Medartis AG washers cleared in K112560.
The subject device Class II accessories (trays and device-specific instruments) have similar designs and are made of identical materials as the Medartis AG Class II accessories and instruments previously cleared in K192297.
CONCLUSION
The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and encompass a similar range of physical dimensions appropriate to the anatomy. The subject device and the primary predicate device are made of the identical material. The data included in this submission demonstrate substantial equivalence to the primary predicate device, the additional predicate devices, and the reference devices listed above.
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Substantial Equivalence – Indications for Use Statements
| Subject Device | Indications for Use Statement |
|---|---|
| K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG | APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula |
| Primary Predicate Device | |
| K013248Synthes (USA) LCP Distal Tibia PlatesSynthes (USA) | The Synthes Locking Compression Plate (LCP) System is intended for fixation of fractures, osteotomies, and non-unions of the claviclefibula, particularly in osteopenic bone. The Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articularas a part of the Synthes Small Fragment LCP System. |
| Additional Predicate Devices | |
| K092812Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia PlatesSynthes (USA) | Synthes 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia |
| K011335Synthes One-third Tubular DCL PlateSynthes (USA) | No 510(k) Summary or Indications for Use Statement are available on the FDA 510(k) database website |
| K083213Synthes 2.7 mm/3.5 mm LCP Distal Fibula PlatesSynthes (USA) | The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal area |
| K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (USA) | Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula |
| K091479APTUS® Foot SystemMedartis AG | The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals |
| Reference Devices | |
| K103332APTUS® Ulna PlatesMedartis AG | APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna. |
| K192297APTUS® Wrist Arthrodesis PlatesMedartis AG | APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis. |
| K191848APTUS® Wrist Spanning Plates 2.5Medartis AG | APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures. |
| a. |
|---|
| cle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, andcular fractures and osteotomies of the distal tibia and other small bones |
| bia, especially in osteopenic bone. |
| d diaphyseal region of the distal fibula, especially in osteopenic bone. |
| a, particularly in osteopenic bone. |
| tatarsals and phalanges. |
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Substantial Equivalence – Technological Characteristics
| Feature | Subject Device | Primary Predicate Device | Additional Predicate Devices | Additional Predicate Device | Reference Device |
|---|---|---|---|---|---|
| K193633APTUS® Ankle Trauma System 2.8/3.5 | K013248Synthes (USA) LCP Distal Tibia Plates | K092812Synthes (USA) 2.7mm / 3.5mm LCPAnterolateralDistal Tibia PlatesK011335Synthes One-third Tubular DCL PlateK083213Synthes 2.7 mm/3.5 mm LCP DistalFibula PlatesK000684Small Fragment Dynamic CompressionLocking (DCL) System | K091479APTUS® Foot System | K103332APTUS® Ulna Plates | |
| Medartis AG | Synthes USA | Synthes USA | Medartis AG | Medartis AG | |
| Product Code | HRS | HRS | HRS, HWC, KTT | HRS, HWC | HRS, HWC |
| Intended Use | Internal fixation of the upper extremity | Internal fixation, including the lowerextremity | Internal fixation, including the lowerextremity | Internal fixation of the lower extremity | Internal fixation of the upper extremity |
| Reason forPredicate/ReferenceDevice | Not applicable | Plate designs, including use with lockingand non-locking screws;Comparison mechanical testing | Plate designs, including use with lockingand non-locking screws;Comparison mechanical testing | Plate designs, including use with lockingand non-locking screws;Compatible screws;Materials ASTM F67 and ASTM F136 | Reference device for comparisonmechanical testing |
| Plates | Anatomic plate designsMultiple designs and sizesScrew holes accommodate locking and non-locking (cortex) screws | Anatomic plate designsMultiple designs and sizesScrew holes accommodate locking and non-locking (cortex) screws | Anatomic plate designsMultiple designs and sizesScrew holes accommodate locking and non-locking (cortex) screws | Anatomic plate designsStraight, T-Shaped, Grid, Wavy and WingMultiple designs and sizesScrew holes accommodate locking and non-locking (cortex) screwsVarious overall dimensionsThickness 1.3 mm to 1.6 mm | Anatomic plate designsMultiple designs and sizesScrew holes accommodate locking and non-locking (cortex) screwsVarious overall dimensionsWidths 7-36 mmLengths 7-184 mmThickness 0.6 mm to 3.2 mm |
| 2.8/3.5 TriLock Distal Tibia PlatesMedialLocking technology- TriLock multidirectional ( $\pm$ 15°) andangular stable locking holes (locking / non-locking)- Oblong holes (non-locking)- One compression hole (non-locking)Implant dimensions- Screw holes total: 11, 13, 15, 17, 19, 21,23, 25- Left and Right- Plate length: 91-260 mm- Plate thickness: 3.25 mm | DePuy Synthes 3.5 mm LCP Low BendMedial Distal Tibia PlateK013248Locking technology- LCP fixed-angle locking holes- LCP combi-holes (locking / non-locking)Implant dimensionsScrew holes in shaft: 4, 6, 8, 10, 12 and 14hole lengths- Left and Right- Plate length: 109-239 mm- Plate thickness: Not stated | ||||
| 2.8/3.5 TriLock Distal Tibia PlatesAnterolateralLocking technology- TriLock multidirectional ( $\pm$ 15°) andangular stable locking holes (locking / non-locking)- Oblong holes (non-locking)Implant dimensions- Screw holes total: 11, 13, 15, 17, 19, 21,23, 25- Left and Right- Plate length: 91-260 mm- Plate thickness: 3.0mm | DePuy Synthes 3.5 mm LCPAnterolateral Distal Tibia PlateK092812, K000684Locking technology- LCP fixed-angle locking holes- LCP combi-holes (locking / non-locking)Implant dimensions-Screw holes in shaft: 4, 6, 8, 10, 12 and 14hole lengths- Left and Right- Plate length: 109-239 mm- Plate thickness: 2.0 mm in the metaphysealregion, 3.6 mm in the diaphyseal region | ||||
| Feature | Subject Device | Primary Predicate Device | Additional Predicate Devices | Additional Predicate Device | Reference Device |
| K193633APTUS® Ankle Trauma System 2.8/3.5 | K013248Synthes (USA) LCP Distal Tibia Plates | K092812Synthes (USA) 2.7mm / 3.5mm LCPAnterolateralDistal Tibia PlatesK011335Synthes One-third Tubular DCL PlateK083213Synthes 2.7 mm/3.5 mm LCP DistalFibula PlatesK000684Small Fragment Dynamic CompressionLocking (DCL) System | K091479APTUS® Foot System | K103332APTUS® Ulna Plates | |
| Medartis AG | Synthes USA | Synthes USA | Medartis AG | Medartis AG | |
| 3.5 TriLock Distal Tibia L Plates andT PlatesLocking technology- TriLock multidirectional (±15°) andangular stable locking holes (locking / non-locking)- Oblong holes (non-locking)Implant dimensions- Screw holes total: 7- Left and Right in L design- Plate lengths: 50 mm- Plate thickness: 2.5 mm2.8/3.5 Distal Fibula Plate Lateral withand without FlapLocking technology- TriLock multidirectional (±15°) andangular stable locking holes (locking / non-locking)- Oblong holes (non-locking)Implant dimensions- Screw holes total: 13, 15, 17, 19, and 21With Flap14,and 16-Left and Right- Plate length: 93-192mm | LCP One-third Tubular Plates 3.5K011335Locking technology- LCP fixed-angle locking holesImplant dimensions- Screw holes: 2-12 holes- Plate length: 28-148 mm- Plate thickness: no information availableLCP Distal Fibula PlatesK083213Locking technology- LCP fixed-angle locking holes- LCP combi-holes (locking / non-locking)Implant dimensions- Screw holes in shaft 3,4,5,6,7,9,11,13 and15- Left and right- Plate thickness: no information available- Plate length: 73-229 mm | ||||
| - Plate thickness: 2.5 mm2.8 Distal Fibula Plate Crossed2.8 Distal Fibula Plate StraightLocking technology- TriLock multidirectional (±15°) andangular stable locking holes (locking / non-locking)- Oblong holes (non-locking)Implant dimensions- Screw holes total: 9,11,13,15 and 17- Plate lengths: 63-119 mm- Plate thickness: 2.5 mm | LCP One-third Tubular Plates 3.5K011335Locking technology- LCP fixed-angle locking holesImplant dimensions- Screw holes: 2-12 holes- Plate length: 28-148 mm- Plate thickness: no information available | ||||
| Feature | Subject Device | Primary Predicate Device | Additional Predicate Devices | Additional Predicate Device | Reference Device |
| K193633APTUS® Ankle Trauma System 2.8/3.5 | K013248Synthes (USA) LCP Distal Tibia Plates | K092812Synthes (USA) 2.7mm / 3.5mm LCPAnterolateralDistal Tibia Plates | K091479APTUS® Foot System | K103332APTUS® Ulna Plates | |
| K011335Synthes One-third Tubular DCL Plate | |||||
| K083213Synthes 2.7 mm/3.5 mm LCP DistalFibula Plates | |||||
| K000684Small Fragment Dynamic CompressionLocking (DCL) System | |||||
| Medartis AG | Synthes USA | Synthes USA | Medartis AG | Medartis AG | |
| Plate Materials | Ti-6Al-4V alloy, ASTM F136 | Titanium alloy, Ti-6Al-7Nb | Titanium alloy, Ti-6Al-7Nb | Unalloyed titanium, ASTM F67 | Unalloyed titanium, ASTM F67 |
| Screws | |||||
| Screw Designs | Subject device screws and previouslycleared Medartis APTUS Screws(K091479, K112560, K110908):Locking screws: cortical thread form, | Compatible screws:Locking screws- 3.5 mm locking screws, length 10 - 65 mmCortical screws | Compatible screws:Locking screws- 3.5 mm locking screws, length 10 - 65 mmCortical screws | Self-tappingconventional (cortex) and locking | Locking screws:Cortical thread form, double-lead thread,self-drilling, self-tapping, fully threadedNon-locking screws: |
| double-lead thread,self-tapping, fully threaded | - 3.5 mm Cortex screws, length 10 - 60 mm | - 3.5 mm Cortex screws, length 10 - 60 mm | Cortical thread form, single-lead thread,self-drilling, self-tapping, fully threaded | ||
| Non-locking screws: cortical thread form,single-leadthread, self-tapping, fully threaded | Cancellous screws- 4.0 mm Cancellous screws, length 10 - 60mm | Cancellous screws- 4.0 mm Cancellous screws, length 10 - 60mm | Previously cleared Medartis APTUS Screws(K051567, K103332):Locking screws:Cortical thread form, double-lead thread,self-tapping, fully threadedNon-locking screws:Cortical thread form, single-lead thread, | ||
| self-tapping, fully threaded | |||||
| Screw Diameters | Subject device screws:3.5 mm locking and non-locking | Locking screws: 2.3, 2.7, 3.5 mmCortical screws: 2.3, 2.7, 3.0, 3.5 mmCancellous screws: 4.0 mm | Locking screws: 2.3, 2.7, 3.5 mmCortical screws: 2.3, 2.7, 3.0, 3.5 mmCancellous screws: 4.0 mm | 2.0 to 2.8 mm | Locking screws: 2.5 mmCortical screws: 1.5 mm, 2.5 mm |
| Previously cleared:2.8 mm (locking and non-locking)3.5 locking | Previously cleared:1.5 mm and 2.5 mm | ||||
| Screw Lengths | Subject device screws:3.5 mm locking: 10 mm to 14 mm3.5 mm non-locking: 10 mm to 60 mmPreviously cleared:2.8 mm locking:8 mm to 60 mm2.8 mm non-locking): 8 mm to 60 mm3.5 mm locking:16 mm to 60 mm | Locking screws8-26 mm (2.3 diameter)8-65 mm (2.7 diameter)6-65 mm (3.5 mm diameter)Cortical screw8-26 mm (2.3 diameter);8-65 mm (2.7 diameter)8-26 mm (3.0 diameter);6-65 mm(3.5 mm diameter)Cancellous screws12-60 mm (4.0 mm diameter) | Locking screws8-26 mm (2.3 diameter)8-65 mm (2.7 diameter)6-65 mm (3.5 mm diameter)Cortical screw8-26 mm (2.3 diameter);8-65 mm (2.7 diameter)8-26 mm (3.0 diameter):6-65 mm(3.5 mm diameter)Cancellous screws12-60 mm (4.0 mm diameter) | 8 to 45 mm | Locking screws: 8 mm to 24 mmCortical screws: 1.5 mm Ø, 8 mm to 15 mm2.5 mm Ø, 8 mm to 24 mmPreviously cleared:Various lengths |
| Screw Materials | Subject device and previously clearedscrews:Ti-6Al-4V alloy, ASTM F136 | Compatible screws:Ti-6Al-4V alloy, ASTM F136; Stainless steel | Compatible screws:Ti-6Al-4V alloy, ASTM F136; Stainless steel | Ti-6Al-4V alloy, ASTM F136 | Ti-6Al-4V alloy, ASTM F136 |
| How Provided | |||||
| Sterility | Provided non-sterile andProvided sterile | Provided non-sterile andProvided sterile | Provided non-sterile andProvided sterile | Provided non-sterile | Provided non-sterile |
| Sterilization | Non-sterile: to be sterilized by moist heatSterile: X-ray beam irradiation | Non-sterile: to be sterilized by moist heatSterile: method not stated | Non-sterile: to be sterilized by moist heatSterile: method not stated | To be sterilized by moist heat | To be sterilized by moist heat |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Reference Device | Reference Device |
|---|---|
| K192297APTUS® Wrist Arthrodesis Plates | K191848APTUS® Wrist Spanning Plates 2.5 |
| Medartis AG | Medartis AG |
| HRS, HWC | HRS, HWC |
| Internal fixation of the upper extremity | Internal fixation of the upper extremity |
| Reference device for ASTM F67 material;Reference device for Class II accessory andinstrument materials | Reference device for ASTM F136 material;Reference device for sterilization and shelflife for product provided sterile |
{9}------------------------------------------------
Substantial Equivalence – Technological Characteristics
| Reference Device | K192297APTUS® Wrist Arthrodesis Plates |
|---|---|
| Medartis AG |
| Reference Device | K191848APTUS® Wrist Spanning Plates 2.5 |
|---|---|
| Medartis AG |
{10}------------------------------------------------
Substantial Equivalence – Technological Characteristics
| Reference Device | Reference Device |
|---|---|
| K192297APTUS® Wrist Arthrodesis Plates | K191848APTUS® Wrist Spanning Plates 2.5 |
| Medartis AG | Medartis AG |
| Unalloyed titanium, ASTM F67 | Ti-6Al-4V alloy, ASTM F136 |
| Previously cleared: | Previously cleared: |
| Ti-6Al-4V alloy, ASTM F136 | Ti-6Al-4V alloy, ASTM F136 |
| Provided non-sterile | Provided sterile |
| To be sterilized by moist heat | X-ray beam irradiation |
| Single-patient, single-use | Single-patient, single-use |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.